Treprostinil Iontophoresis in Diabetic Foot Ulcers: A Single Ascending Dose Safety Study.

BACKGROUND

Diabetic foot ulcers (DFUs) represent a serious public health problem associated with significant morbidity and health costs. Despite optimal etiologic treatment and local care, amputation is frequent, stressing the need for new treatments. The benefit of systemic administration of vasodilators, such as prostacyclin analogues, has proven efficacy in other types of skin ulcers, but it is counterbalanced by potentially serious vasodilation-induced, concentration-dependent, adverse effects. Experimental data has shown the feasibility of local administration of treprostinil on the wound using iontophoresis.

OBJECTIVE

We aimed to assess the safety of the local iontophoretic administration of treprostinil in patients with DFU through a single ascending dose safety study.

METHODS

We conducted a prospective single ascending dose phase I study. Patients received a single dose of treprostinil applied via iontophoresis at a current density of 0.2 mA/cm2 for 30 min. Local and systemic adverse effects were monitored, and plasma treprostinil concentrations were measured over an 8-h follow-up period.

RESULTS

Four patients were included, and received single doses of 0.025, 0.05, 0.1, and 0.25 mg/L at 0.2 mA/cm2 during 30 min, and were followed-up for 8 h. All patients did not present any significant adverse effect. Plasma concentration was below < 1.8 ng/mL 8 h after the administration.

CONCLUSIONS

Our results suggest that iontophoresis of treprostinil is a safe procedure at 0.25 mg/mL, without systemic adverse effect, suggesting its potential as a targeted treatment for DFUs.